Catheter securement device

ABSTRACT

A securement system ( 100 ) includes a device which permits a portion of a catheter or similar medical article to be easily anchored to a patient, desirably without the use of tape or needles and suture. A securement system for an elongated medical article comprises an anchor pad ( 110 ) and a retainer ( 120 ) mounted upon the anchor pad. The retainer ( 120 ) includes a channel ( 130 ) that has at least one abutment surface ( 160 ) corresponding to a contact surface on the medical article and a groove ( 210 ) configured to receive a spline ( 40 ) of the medical article. The medical article is placed into the channel ( 130 ). The medical article is secured within the channel by retaining at least one spline ( 40 ) and contact surface on the medical article.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of co-pending U.S. application Ser.No. 13/254,797, filed Sep. 2, 2011, entitled “CATHETER SECUREMENTDEVICE,” which is the U.S. National Phase under 35 U.S.C. §371 of priorPCT International Application No. PCT/US2010/026278, filed Mar. 4, 2010,entitled “CATHETER SECUREMENT DEVICE,” which claims priority under 35U.S.C. §119(e) to U.S. Provisional Application No. 61/157,532, filedMar. 4, 2009, entitled “CATHETER SECUREMENT DEVICE,” all of which arehereby incorporated by reference in their entireties.

BACKGROUND

1. Field of the Invention

This invention relates to a securement system used to attach a medicalline to a patient.

2. Description of the Related Art

It is common in the treatment of patients to utilize catheters tointroduce fluids and medications directly into the patient or towithdraw fluids from the patient. Often, it becomes desirable tomaintain such catheterization over an extended period of time during thetreatment of a patient. In order to keep the catheter or other medicalline properly positioned for the duration of treatment, the catheter ormedical line can be secured to the patient in a variety of ways. Mostcommonly, this involves taping the catheter or medical line to thepatient.

Securing a catheter with tape upon the patient traditionally has certaindrawbacks. The use of tape at the insertion site can retain dirt orother contaminant particles, potentially leading to infection of thepatient. Tape also fails to limit catheter motion and, therefore,contributes to motion related complications like phlebitis, infiltrationand catheter migration. Additionally, removal of taped dressings canitself cause undesired motion of the catheter upon the patient.

Taped dressings also require periodic changes. The frequent, oftendaily, removal and reapplication of adhesive tape to the skin of thepatient can excoriate the skin in the area around the dressing. Suchrepeated applications of tape over the catheter or medical line canadditionally lead to the build up of adhesive residue on the outersurface of the catheter or medical line. This residue can result incontaminants adhering to the catheter itself, increasing the likelihoodof infection of the insertion site. This residue can also make thecatheter or medical line stickier and more difficult to handle forhealthcare providers.

SUMMARY OF THE INVENTION

The devices and methods of the present invention have several features,no single one of which is solely responsible for its desirableattributes. Without limiting the scope of this invention as expressed bythe claims which follow, its more prominent features will now bediscussed briefly. After considering this discussion, and particularlyafter reading the section entitled “Detailed Description of CertainEmbodiments” one will understand how the features of this inventionprovide several advantages over other implantable medical articles.

One aspect of the present invention is a securement system for securinga medical article to the skin of a patient. The system comprises ananchor pad that has a lower surface at least partially covered by anadhesive for contacting the patient's skin and a medical article thathas a generally elongated tubular body, a ridge circumscribing at leasta portion of the tubular body, and at least one spline extendinggenerally perpendicular to the ridge and on either side of the ridge.The ridge defines a contact surface. The system further includes aretainer being supported by the anchor pad. The retainer has a pair ofupstanding walls separated by a base region to define a channeltherebetween, a longitudinal access opening disposed on an upperside ofthe retainer, and at least one groove disposed in the channel andgenerally parallel to the channel. The at least one groove being sizedand shaped so as to receive at least a portion of the spline when themedical article is secured within the retainer. The retainer furtherincluding an abutment surface disposed in the channel and generallyperpendicular to the at least one groove. The abutment surfacecooperating with the contact surface on the medical article to inhibitlongitudinal movement of the medical article relative to the retainer inat least one direction when the spline is disposed within the groove andthe medical article is secured within the retainer.

Another aspect of the present invention is a retainer for securing amedical article. The medical article has a generally elongated tubularbody, a ridge circumscribing at least a portion of the tubular body, andat least one spline extending generally perpendicular to the ridge andon either side of the ridge. The ridge defines a contact surface. Theretainer includes a pair of upstanding walls separated by a base regionto define a channel therebetween and at least one groove disposed in thechannel. The at least one groove being sized and shaped so as to receiveat least a portion of the at least one spline of the medical article.The retainer further including an abutment surface disposed in thechannel and generally perpendicular to the at least one groove. The atleast one abutment surface cooperating with the contact surface toinhibit longitudinal movement of the medical article relative to theretainer in at least one direction at least when the spline is disposedwithin the groove and the medical article is secured within theretainer.

Another aspect of the present invention is a method of securing amedical article to a patient. The medical article has a generallyelongated tubular body, a ridge circumscribing at least a portion of thetubular body, and a pair of splines extending generally perpendicular tothe ridge and on either side of the ridge. The ridge defines a contactsurface. The method includes providing a retainer having a channel, apair of longitudinal grooves disposed within the channel and separatedby a base surface, and at least one abutment, locating the retainer withrespect to the medical article so as to generally align the pair ofsplines with the pair of grooves, and pushing the medical articletowards the channel so that at least a portion of the splines arereceived within the groves. The method further includes sliding thesplines of the medical article in the grooves until the contact surfaceof the medical article abuts the at least one abutment surface.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the securement device configured inaccordance with a preferred embodiment of the present invention.

FIG. 2 is a top plan view of the retainer and anchor pad of FIG. 1.

FIG. 3 is a top plan view of the retainer of FIG. 2.

FIG. 4 is a bottom view of the retainer of FIG. 3.

FIG. 5 is a front side view of the retainer of FIG. 3.

FIG. 6 is a rear side view of the retainer of FIG. 3.

FIG. 7 is a side view of the retainer of FIG. 3.

FIG. 8 is an opposite side view of the retainer of FIG. 3.

FIG. 9 is a front perspective view of the retainer of FIG. 3.

FIG. 10 is a rear perspective view of the retainer of FIG. 3.

FIG. 11 is a cross-sectional view of the retainer of FIG. 3, taken alongthe 11-11 line.

FIG. 12 is a cross-sectional view of the retainer of FIG. 3, taken alongthe 12-12 line.

FIG. 13 is a cross-sectional view of the retainer of FIG. 3, taken alongthe 13-13 line.

FIG. 14 is a perspective view of a catheter hub arranged above theretainer of the securement device from FIG. 1.

FIG. 15 is a perspective view of the catheter hub secured to theretainer of the securement device from FIG. 1.

FIG. 16 is a perspective view of the securement device configured inaccordance with another preferred embodiment of the present inventionthat includes an adhesive spot and an incident angle of seven degrees.

FIG. 17 is a top plan view of the retainer and anchor pad of FIG. 16.

FIG. 18 is a top plan view of the retainer of FIG. 17 showing theadhesive spot in a channel of the retainer.

FIG. 19 is a bottom view of the retainer of FIG. 18.

FIG. 20 is a front side view of the retainer of FIG. 18.

FIG. 21 is a rear side view of the retainer of FIG. 18.

FIG. 22 is a side view of the retainer of FIG. 18.

FIG. 23 is an opposite side view of the retainer of FIG. 18.

FIG. 24 is a front perspective view of the retainer of FIG. 18.

FIG. 25 is a rear perspective view of the retainer of FIG. 18.

FIG. 26 is a cross-sectional view of the retainer of FIG. 18, takenalong the 26-26 line.

FIG. 27 is a cross-sectional view of the retainer of FIG. 18, takenalong the 27-27 line.

FIG. 28 is a cross-sectional view of the retainer of FIG. 18, takenalong the 28-28 line.

FIG. 29 is a perspective view of a catheter hub arranged above theretainer of the securement device from FIG. 16.

FIG. 30 is a perspective view of the catheter hub secured to theretainer of the securement device from FIG. 16.

FIG. 31 is a perspective view of the securement device configured inaccordance with another preferred embodiment of the present inventionthat includes an incident angle of approximately seven degrees.

FIG. 32 is a top plan view of the retainer and anchor pad of FIG. 31.

FIG. 33 is a top plan view of the retainer of FIG. 32.

FIG. 34 is a bottom view of the retainer of FIG. 33.

FIG. 35 is a front side view of the retainer of FIG. 33.

FIG. 36 is a rear side view of the retainer of FIG. 33.

FIG. 37 is a side view of the retainer of FIG. 33.

FIG. 38 is an opposite side view of the retainer of FIG. 33.

FIG. 39 is a front perspective view of the retainer of FIG. 33.

FIG. 40 is a rear perspective view of the retainer of FIG. 33.

FIG. 41 is a cross-sectional view of the retainer of FIG. 33, takenalong the 41-41 line.

FIG. 42 is a cross-sectional view of the retainer of FIG. 33, takenalong the 42-42 line.

FIG. 43 is a cross-sectional view of the retainer of FIG. 33, takenalong the 28-28 line.

FIG. 44 is a perspective view of a catheter hub arranged above theretainer of the securement device from FIG. 31.

FIG. 45 is a perspective view of the catheter hub secured to theretainer of the securement device from FIG. 31.

FIG. 46 is a perspective view of the securement device configured inaccordance with another preferred embodiment of the present inventionthat includes an adhesive spot and an incident angle of approximatelyseven degrees.

FIG. 47 is a top plan view of the retainer and anchor pad of FIG. 46.

FIG. 48 is a top plan view of the retainer of FIG. 47.

FIG. 49 is a bottom view of the retainer of FIG. 48.

FIG. 50 is a front side view of the retainer of FIG. 48.

FIG. 51 is a rear side view of the retainer of FIG. 48.

FIG. 52 is a side view of the retainer of FIG. 48.

FIG. 53 is an opposite side view of the retainer of FIG. 48.

FIG. 54 is a front perspective view of the retainer of FIG. 48.

FIG. 55 is a rear perspective view of the retainer of FIG. 48.

FIG. 56 is a cross-sectional view of the catheter hub from FIG. 60secured within the retainer of FIG. 48, taken along the 56-56 line.

FIG. 57 is a cross-sectional view of the catheter hub from FIG. 60secured within the retainer of FIG. 48, taken along the 57-57 line.

FIG. 58 is a cross-sectional view of the retainer of FIG. 48, takenalong the 58-58 line.

FIG. 59 is a perspective view of a catheter hub arranged above theretainer of the securement device from FIG. 46.

FIG. 60 is a perspective view of the catheter hub secured to theretainer of the securement device from FIG. 46.

FIG. 61 is a perspective view of the securement device configured inaccordance with another preferred embodiment of the present inventionthat includes an incident angle of approximately ten degrees.

FIG. 62 is a top plan view of the retainer and anchor pad of FIG. 61.

FIG. 63 is a top plan view of the retainer of FIG. 62.

FIG. 64 is a bottom view of the retainer of FIG. 63.

FIG. 65 is a front side view of the retainer of FIG. 63.

FIG. 66 is a rear side view of the retainer of FIG. 63.

FIG. 67 is a side view of the retainer of FIG. 63.

FIG. 68 is an opposite side view of the retainer of FIG. 63.

FIG. 69 is a front perspective view of the retainer of FIG. 63.

FIG. 70 is a rear perspective view of the retainer of FIG. 63.

FIG. 71 is a cross-sectional view of the catheter hub from FIG. 74secured within the retainer of FIG. 63, taken along the 71-71 line.

FIG. 72 is a cross-sectional view of the catheter hub from FIG. 74secured within the retainer of FIG. 63, taken along the 72-72 line.

FIG. 73 is a cross-sectional view of the retainer of FIG. 63, takenalong the 73-73 line.

FIG. 74 is a perspective view of a catheter hub arranged above theretainer of the securement device from FIG. 61.

FIG. 75 is a perspective view of the catheter hub secured to theretainer of the securement device from FIG. 61.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

The following description and the accompanying figures, which describeand show the preferred embodiments, are made to demonstrate severalpossible configurations that a securement system can take to includevarious aspects and features of the invention. The illustratedembodiments are shown in use with an illustrative example of a catheterhub used for connection to a connector fitting via a spin nut. Theillustration of the securement device in this context is not intended tolimit the disclosed aspects and features of the invention to thespecified embodiments or to usage only with the illustrated catheterhub. Those of skill in the art will recognize that the disclosed aspectsand features of the invention are not limited to any particularembodiment of a securement system, and securement systems, which includeone or more of the inventive aspects and features herein described, canbe designed for use with a variety of medical articles.

To assist in the description of these components of the securementsystem, the following coordinate terms are used (see FIG. 1). A“longitudinal axis” is generally parallel to a portion of the catheterhub or other medical article retained by the securement system, as wellas parallel to the axis of a channel of the retainer, through which themedical article extends. A “lateral axis” is normal to the longitudinalaxis. A “transverse axis” extends normal to both the longitudinal andlateral axes. In addition, as used herein, “the longitudinal direction”refers to a direction substantially parallel to the longitudinal axis;“the lateral direction” refers to a direction substantially parallel tothe lateral axis; and “the transverse direction” refers to a directionsubstantially parallel to the transverse axis. The term “axial” as usedherein refers to the axis of the channel or catheter hub, and thereforeis substantially synonymous with the term “longitudinal” as used herein.Also, the terms “proximal” and “distal”, which are used to describe thepresent securement system, are used consistently with the description ofthe exemplary applications. Thus, proximal and distal are used inreference to the center of the patient's body. The terms “upper,”“lower,” “top,” “bottom,” “underside,” “upperside” and the like, whichalso are used to describe the present securement system, are used inreference to the illustrated orientation of the embodiment. For example,the term “upperside” is used to describe the portion of the retainerthat is located above a lateral axis that passes through the axis of thechannel. The term “underside” is used to describe the portion of theretainer that is located below a lateral axis that passes through theaxis of the channel. Brief introductions to some of the features, whichare common to the described embodiments of the securement systems, arenow described.

The preferred embodiments of the present invention advantageouslyprovide a medical line securement system for securing a medical articleto a patient. The medical article preferably has an elongated body. Theelongated body cooperates with a retainer to arrest movement of themedical article in longitudinal, lateral, and transverse directions whenplaced within the retainer.

In each of the embodiments described below, the retainer has a body thatdefines a central channel disposed above a base surface. The centralchannel receives a portion of the medical article. The retainer has alongitudinal access opening located on an upperside of the retainer.This access opening allows ingress or egress of the medical article.Alternatively, the medical article may be inserted in a proximaldirection, or from the rear, into the channel of the retainer along thelongitudinal axis. The medical article can be removed by sliding themedical in a distal direction or transverse direction. Such anarrangement allows the medical provider to align at least a portion ofthe medical article with the retainer before or after fixing theretainer to the patient's skin.

The retainer includes at least one abutment (preferably an abutmentsurface) that cooperates with at least one contact point or surface onthe medical article. The one or more abutments of the retainer extendgenerally normal to the longitudinal axis and can be, for example, butwithout limitation a surface, a wall of a slot, a wall of a groove, aridge, a protuberance, or like structures. For example, the groove canextend from a distal most end of the retainer along the longitudinalaxis and partway towards the proximal end of the retainer. An abutmentis formed at the location where the groove terminates. The abutmentcooperates with the one or more contact points or surfaces of themedical article to inhibit longitudinal movement of the medical articlethrough the retainer in at least a proximal direction.

At least one of the abutments is located between the ends of theretainer. The abutment will act against at least a portion of anoutwardly extending member or step which defines the one or more contactpoints or surfaces of the medical article. In this way, the medicalarticle will be limited in its proximal movement (i.e., movement towardthe patient) once the step contacts or abuts against the abutment of theretainer. In some embodiments, an adhesive is used to further inhibitrelative movement of the medical article with respect to the retainer.The retainer can have a unitary or non-unitary construction.

Ingress or egress of the medical article from the retainer may befacilitated by manipulation of the retainer. For example, a healthcareprovider can bend or flex the walls apart from the medical article toease ingress or egress of the medical article with the channel.

The retainer further inhibits distal movement of the retained medicalarticle. For example, frictional contact between the medical article andthe retainer can inhibit distal movement as can the actual shape of themedical article. An adhesive region of the channel surface can furtherinhibit distal movement. An adhesive wrap or cover may be employed toadhere the medical article relative to the anchor pad and retainer.

The retainer of each embodiment described below further includes ananchor pad. The lower surface of the anchor pad attaches to thepatient's skin. The anchor pad may include an adhesive, such as aHydrocolloid and Zinc Oxide adhesive. Such an adhesive may provideadditional advantages in humid environments, such as typically found ina neonatal intensive care unit.

The anchor pad inhibits contact between the skin and the retainer, withthe retainer and anchor pad inhibiting contact between the skin and theretained portion of the medical article.

To facilitate a complete understanding of the embodiment, the remainderof the detailed description describes the securement system withreference to the figures, wherein similar elements among the embodimentsare referenced with like numerals throughout the following description.

FIG. 1 is a perspective view of a securement system 100 configured inaccordance with an embodiment of the present invention. As shown in FIG.1, the illustrated securement system 100 comprises two main components:an anchor pad 110 and a retainer 120. The flexible anchor pad 110 has anadhesive bottom side that attaches to the skin of a patient when used.The pad 110 can be attached at any number of locations on a patient'sbody. Thus, the securement system 100 can be used for catheterization atany location on the patient's body, e.g., on the back of the hand,medial side of the wrist in connection with catheterization of a radialartery, or on the anterior or posterior of the patient's torso inconnection with epidural catheterization. The pad 110 supports theretainer 120. The retainer 120 in turn is configured to receive andsecure in place the catheter hub 10.

As noted above, the securement system 100 can form a component of asecurement system that also includes one or more medical articles, suchas connector fittings, catheters, hubs, catheter adaptors, fluid supplylines, or other articles suitable for securement via the anchor pad andretainer. An opening in the retainer 120 is aligned with the medicalarticle. The medical article is inserted through the opening and intothe retainer 120. The anchor pad 110 is then secured to the skin of thepatient, generally by an adhesive disposed upon the bottom surface ofthe pad. Alternatively, the anchor pad 110 may first be secured to thepatient with the medical article being secured within the retainer 120.In this way, the retainer 120 secures the medical article to thepatient. Thus, the retainer at least restricts, if not prevents, lateraland transverse movement of the retained section of the medical article.Additional features of the securement system 100 can restrict, if notprevent longitudinal movement of the retained section of the medicalarticle in at least one direction. The embodiment illustrated ispreferably for use with a catheter hub as described with reference toFIGS. 14 and 15. The embodiments of the anchor pad and the retainer aredescribed in more detail below.

Catheter Hub

With reference to FIG. 14, a coupling is formed between a catheter hub10 and a connector 20. Although the catheter hub 10 is illustrated asbeing a BD L-Cath Catheter for use with PICC and Midline catheters ofthe type disclosed in publication “The BD Family of PICC and MidlineCatheters” published by BD Medical of Sandy, Utah, which is herebyincorporated by reference in its entirety and attached hereto, othertypes of catheters and adaptors can be used as well with the presentsecurement system 100. Those skilled in the art can readily select thetype of catheter to be used with the present securement system 100 andcan modify the securement system according to the teachings of thepresent invention to suit the particular application (e.g., venous,arterial, epidural, peripheral, etc.).

Thus, the principles of the present invention are not limited tocatheters or to the specific type of catheter disclosed in thepublication “The BD Family of PICC and Midline Catheters.” Instead, itwill be understood by one of skill in this art, in view of the presentdisclosure, that the securement system disclosed herein also can besuccessfully utilized in connection with other types of catheters,including those with other arrangements of splines with differentlengths or of staggered positions along the catheter hub tubular body.In addition, it will be understood by one of skill in this art that thesecurement system disclosed herein also can be successfully utilized inconnection with other types of medical articles, including other typesof catheters, fluid drainage and delivery tubes, and electrical wires.For example, but without limitation, the retainer disclosed herein canbe configured to secure peripheral catheters, peripherally insertedcentral catheters, hemodialysis catheters, surgical drainage tubes,feeding tubes, chest tubes, nasogastric tubes, scopes, as well aselectrical wires or cables connected to external or implanted electronicdevices or sensors. One skilled in the art may also find additionalapplications for the devices and systems disclosed herein. Thus, theillustration and description of the securement system in connection witha catheterization system, which includes a catheter hub similar to thatdisclosed in the publication “The BD Family of PICC and MidlineCatheters,” merely exemplifies one possible application of the presentsecurement system.

As best seen in FIGS. 14 and 15, the catheter hub 10 comprises a tubularbody 30 having a plurality of diameters along the longitudinal length ofthe body 30 between the longitudinal ends of the splines 40. Theillustrated body 30 includes a first diameter 30(a) and a seconddiameter 30(b) disposed on the proximal side of the first diameter30(a). A ridge is formed at the intersection of the two diameters.Preferably the first diameter 30(a) is greater that the second diameter30(b) so as to form a plurality of contact surfaces facing in theproximal direction at the interface between the first and seconddiameters. In the illustrated embodiment, four contact surfaces areformed on the tubular body 30 at this location. The longitudinal lengthof the tubular body 30 corresponding to the first diameter 30(a) islength L₁.

The proximal end of the tubular body 30 includes a series of axiallyextending splines 40 projecting outward from the tubular body 30. Inparticular, the tubular body 30 includes at least four axially elongatedsplines 40 that are equally spaced around the tubular body 30. Thesplines 40 lie at a position 90° apart from each other. The splines 40have a generally rectangular shape that tapers to a rounded surface onthe lateral edge of the rectangular body. The splines 40 have alongitudinal length L₂.

The catheter hub 10 includes a third diameter adjacent to the distalside of the first diameter 30(a). Four additional contact surfaces areformed at the interface between the first and third diameters. Thedistal end of the catheter hub 10 is configured to engage the proximalend of the connector 20. A central lumen extends through the tubularbody 30. The connector 20 includes a spin nut 50 disposed on its distalend. The spin nut 50 comprises a generally tubular sleeve having acylindrical exterior surface, a proximal annular flange, and a series ofaxially extending grip rails.

Retainer

FIGS. 3-13 illustrate the retainer 120, which is configured inaccordance with a preferred embodiment of the present invention. Theretainer 120 defines a central channel 130 disposed above a base regionor base surface 140. As seen in FIG. 2, the retainer 120 includesproximal and distal end portions 190, 200. The channel 130 extendsthrough these portions 190, 200 and is open at each of its ends throughend walls of the retainer 120. The channel 130 extends about a central,longitudinally extending axis C and has an opening 150 that faces awayfrom the base surface 140. At least a portion of the channel 130 has alateral width that is smaller than a diameter of a portion of thecatheter so as to define one or more abutment surfaces, as describedbelow in greater detail.

As best seen in FIG. 6, the retainer 120 also includes a plurality ofabutment surfaces 160, 180. The abutment surfaces extend outwardly fromthe channel 130 along the central axis C. The abutment surfaces can bedisposed between the proximal and distal ends of the retainer 120 and/oron one or both ends of the retainer 120.

FIGS. 7 and 8 illustrate that the channel axis C is parallel to the basesurface 140 of the retainer 120. An incident angle θ is defined betweenthe base surface 140 and the channel axis C. Additional embodimentsdisclosed herein include various incidents angles to provide minimalstress and strain on the inserted catheter lumen.

FIGS. 9 and 10 illustrate the walls 170 of the retainer 120 betweenwhich the channel 130 passes. At least some of the abutment surfaces aredefined by grooves in the retainer 120. For example, longitudinallyextending grooves 210 formed in the walls 170 define intermediateabutment surfaces 160 at the proximal ends of the grooves 210. Theseabutment surfaces 160 are formed on an inner side of the wall 170 orbase surface 140, and in the illustrated embodiment, are disposed nearthe middle of the retainer along the central or longitudinal axis C. Inthe illustrate embodiment, there are three intermediate surfaces 160,one in each of the base surface 140 and side walls 170. Eachintermediate surface 160 lies generally normal to the central axis C ofthe channel 130 and is laterally aligned with the other two intermediatesurfaces 160. The abutment surface can be discontinuous and/orcircumscribe the channel foil approximately 180 degrees.

The plurality of abutment surfaces further includes one or moredistal-most abutment surfaces 180. The intermediate surfaces 160 liebetween the proximal-end of the retainer 120 and the distal-mostabutment surfaces 180 and are defined on the side walls 170 and basesurface 140. The distal-most abutment surfaces 180 and the intermediatesurfaces 160 preferably are separated by a distance that is generallyequal to the longitudinal length between steps along the tubular body ofthe catheter hub. For example, the longitudinal length of the grooves210 is preferably equal to or less than length L1 as illustrated in FIG.14.

With the groove 210 having a length of no greater than L1, theintermediate surfaces 160 are disposed from the distal end portion 200the same as or less than the distance corresponding to the longitudinallength of the first diameter 30(a) of the catheter hub 10. In this way,the proximal facing contact surfaces on the first diameter 30(a) willcontact the intermediate surfaces 160 when the catheter hub is securedwithin the retainer 120.

Each wall 170 additionally has a generally flat, upstanding surfacedefined between the proximal end portion 190 and the distal end portion200. The grooves 210 are defined in the upstanding surface and have aconcave shape relative to the channel axis C. The radius of curvaturepreferably matches or at least approximates the radius of the firstdiameter 30(a) of the catheter hub 10. The grooves 210 of the channelinhibit unintentional transverse movement of catheter hub 10. For thispurpose, the grooves 210 together have a generally truncated, circularcross-sectional shape that extends through an arc of greater than 180°.The grooves 210 have a diameter sized to receive the first diameter30(a) of the tubular body 30. In an exemplifying embodiment, the grooves210 together extend through an arc of about 200° about the channel axisC. As most clearly shown in FIG. 11, the channel section, incross-section, thus extends through an arc of a little more than 180°about the channel axis c such that the lateral width of the opening 150is slightly smaller to the overall diameter of the grooves 210. Thisallows for the tubular body 30 of the catheter hub 10 to be snapped intothe central channel 130.

The edge of each wall 170 located above each groove 210 thus reduces thelateral width of the channel 130 as defined between the edges of eachwall 170. In this manner, the walls 170 either grip onto or at leastextend over the first diameter 30(a) portion of the catheter hub 10 toinhibit unintentional transverse movement of the catheter hub 10 oncesituated within the retainer 120.

As best seen in FIGS. 11 and 12, the upper side surfaces of the walls170 preferably are rounded or chamfered and slope toward the channelopening 150 to guide the catheter hub 10 and the splines 40 into thechannel 130. As a result, the catheter hub 10 slides more smoothly overthe upper side surfaces and into the channel 130 as the walls 170 aredeflected outwardly by the interference with the splines 40 of thecatheter hub during the insertion process. Alternatively, the catheterhub 10 may be slid in a proximal direction along the longitudinal axisand into the channel 130. In this way, the walls 170 need not deflectoutwardly as the catheter hub 10 is inserted into the retainer 120 sincethe first diameter 30(a) and splines 40 enter the grooves 210, 220,respectively, on the distal portion 200 of the retainer.

The walls 170 preferably wrap around a sufficient amount of the catheterhub 10 to inhibit unintentional transverse movement of the catheter hub10 relative to the retainer 120. As understood from the abovedescription, the upper ends of the walls 170 are disposed inward fromthe concave surfaces of the grooves 210 to narrow the lateral width ofthe channel opening 150 above the grooves 210. The extent to which theupper ends can be disposed inward is limited, however, in order topermit insertion of the splines 40 into the channel 130 through theopening 150. Accordingly, the grooves 210 preferably have a lengthsufficient to produce the desired retention strength to hold thecatheter hub 10 in the retainer 120 against an upwardly directed force(or force component). Of course, where the retainer 120 includes one ormore additional mechanisms to resist transverse movement of the catheterhub 10 relative to the retainer 120—for example, covering at least aportion of the inner channel surface with an adhesive or overlying thesecured catheter hub 10 and retainer 120 with an adhesive cover—thelength of the grooves 210 can be reduced.

In a preferred mode, the walls 170 also have a sufficient length toprevent the catheter hub 10 from yawing (i.e., movement side to side ina longitudinal-lateral plane). That is, the length of the walls 170,which interacts with the tubular body 30, is sufficient so that thefirst diameter 30(a) portion does not act as a fulcrum. However, whilesuch wall length is preferred, the wall length can be significantlyshorter (e.g., interact with the catheter hub at a single longitudinalpoint) where the catheter hub is also held near its proximal end by thewalls 170.

As best seen in FIG. 12, each wall 170 adjacent to the groove 210 has alateral thickness that decreases from the base surface 140 of theretainer 120 to the top of the retainer 120. The decreased lateralthickness of the walls 170 provides increased flexibility to permit thewalls 170 to deflect elastically outwardly when pressing the catheterhub 10 into the channel 130.

The distal ends of the side walls 170 define at least a portion of thedistal-most abutment surfaces 180. In the illustrated embodiment, thedistal-most abutment surfaces 180 are generally upright.

As seen in FIGS. 2, 10, and 13, the lower groove 210 is defined in theretainer 120 from the distal end portion 200 towards the proximal endportion 190 and between the walls 170, and extends into the base surface140. The longitudinal length of the groove 210 in the base surface 140preferably matches the longitudinal lengths of the grooves 210 in thewalls 170. In the illustrated embodiment, the groove 210 in the basesurface 140 is deep enough to receive a portion of the first diameter30(a) of the tubular body 30.

As seen in FIGS. 2, 9, 12, and 13, at the intersections of the walls 170and the base surface 140 area pair of grooves 220 defined in theretainer 120 which extend from the distal end portion 200 to theproximal end portion 190. The longitudinal length of the grooves 220 inthe base surface 140 preferably extends for the entire length of thechannel 130. In the illustrated embodiment, the grooves 220 in the basesurface 140 are deep enough to receive one or more of the splines 40that may extend downward when the catheter hub 10 is inserted into theretainer 120. Portions of the grooves 220 open into the groove 210 attheir lateral inward sides.

As is illustrated in FIG. 12, the cross-section of the channel 130 nearthe proximal end portion 190 generally has a U-shaped cross-section witha radius of curvature at least as large as the radius of the seconddiameter 30(b) portion of the tubular body 30. The radius of curvaturecan be larger than the radius of the second diameter 30(b) to facilitatesecurement.

Both the proximal opening as illustrated in FIG. 5 and the proximalportion 190 of the channel 130 have generally U-shapes; however, one orboth of these channel sections can have a truncated, generally circularshape. In this variation, the opening or the proximal channel sectioncan receive the second diameter 30(b) portion of the catheter hub 10 ina snap fit manner, similar to the distal end portion 200 of the retainer120, to inhibit further transverse movement of the catheter hub 10relative to the retainer 120.

As illustrated in FIGS. 7 and 8, the retainer 120 includes fingerplatforms 230 on both sides of the central channel 130. Each fingerplatform 230 extends laterally from one side of the retainer 120. Eachfinger platform 230 may have a ribbed upper surface to improvefrictional contact between a healthcare provider's fingers and theplatform 230. The finger platforms 230 are sized and configured to allowa healthcare provider to press the retainer 120 against the skin of thepatient while pulling up on the catheter hub 10 when disengaging thecatheter hub 10 from the retainer 120. Alternatively, the healthcareprovider may use the platforms 230 to resist movement of the retainer120 when disengaging the catheter hub 10 from the retainer 120 bysliding the catheter hub 10 in a distal direction.

The retainer 120 is made of relatively stiff plastic material (e.g.,polycarbonate), but is somewhat flexible such that the catheter hub 10will force the walls 170 outwardly when a healthcare provider pressesthe catheter hub 10 into the central channel 130 of the retainer 120.When the tubular body 30 sits in the central channel 130, the upperedges of the walls 170 snap inwardly to their original position tosecurely hold the catheter hub 10 within the retainer 120.

The retainer 120 may be constructed in any of a variety of ways whichwill be well known to one of skill in the art. For instance, retainer120 may be integrally molded such as by injection molding or bythermoplasty. The retainer 120 preferably comprises a durably, flexiblematerial, and more preferably comprise a generally inert, non-toxicmaterial. Suitable materials include plastics, polymers, or compositessuch as polypropylene, polyethylene, polycarbonate, polyvinylchloride,polyurethane, tetrafluoroethylene (e.g., TEFLON7),polytetrafluoroethylene (a.k.a., PTEF), acetal resin (e.g., DELRIN7),chlorotrifluoroethylene (e.g., KEL-F7), acrylonitrile butadiene styrene,styrene butadiene, nylon, olefin, acrylic, polyester, moldable silicon,thermoplastic urethane, thermoplastic elastomers, thermoset plastics andthe like. The retainer 120 can be formed by injection molding using apolycarbonate, available commercially from GE Plastics (Seewww.geplastics.com). However, other materials can be used.

Anchor Pad

As is seen in FIG. 1, the anchor pad 110 is a substantially flat pieceof material with transversely opposing sides. The lower side of the pad110 faces toward the skin of the patient, and is preferably covered withan adhesive surface suitable for attaching the anchor pad 110 to theskin of the patient. The entire surface, however, need not be covered.An upper side of the anchor pad 110 faces away from the skin of thepatient and supports the retainer 120.

The anchor pad 110 may comprise a laminate structure with an upper foamlayer (e.g., closed-cell polyethylene foam) and a lower adhesive layer.Such foam with an adhesive layer is available commercially from TycoAdhesives of Norwood, Mass. The lower adhesive layer constitutes thelower surface of the anchor pad 110, i.e., it is coextensive with theupper foam layer. The lower surface desirably is a medical-gradeadhesive and can be either diaphoretic or nondiaphoretic, depending uponthe particular application. The adhesive may be a Hydrocolloid and ZincOxide adhesive. Such an adhesive may provide additional advantages inhumid environments, such as typically found in neonatal intensive careunit.

A surface of the upper foam layer constitutes the upper surface of theanchor pad 110. The upper surface can be roughened by chemical primingor by corona-treating the foam with a low electric charge. The roughenedor porous upper surface can improve the quality of the adhesive joint(which is described below) between the retainer 120 and the anchor pad110. In the alternative, the flexible anchor pad 110 can comprise amedical-grade adhesive lower layer, an inner foam layer and an upperpaper or other woven or non-woven cloth layer.

The anchor pad 110 generally has a rectangular shape with roundedcorners. In the embodiment illustrated in FIG. 31, the anchor padfurther includes elongated extensions that project from the generallyrectangular shape in a proximal direction. The elongated sections form aconcave section or notch, as shown in FIG. 31, that narrows the centerof the anchor pad 110 proximate to the retainer 120 and on a proximalside of the pad 110. The notch facilitates viewing the indwellingcatheter, cleansing the insertion site, and placing the anchor pad 110about the insertion site. This shape also permits the anchor pad 110 tobe placed on the patient such that the anchor pad extends beyond theinsertion site in the proximal direction, and away from the insertionsite in the lateral direction. By aligning the anchor pad 110 and theinsertion site of the catheter in this manner, enhanced stability isprovided to the catheter. This also minimizes the free length of thecatheter between the insertion site and the channel 130 of the retainer120, helping prevent inadvertently catching or pulling on and dislodgingof the catheter as the patient moves or as healthcare providers tend tothe patient. A smaller anchor pad 110, such as is illustrated in FIG. 1,may be preferred where the receiving surface on the patient is smallsuch as on a child or baby.

The retainer 120 is preferably centered upon the anchor pad 110.Consequently the lateral sides of the anchor pad 110 have more contactarea with the skin, both distally and proximally of the retainer 120 inthe longitudinal direction, which provides greater stability andadhesion to the skin while still permitting the retainer 120 to belocated near the insertion site. Although not illustrated, the anchorpad 110 also can include suture and/or breather holes which arepositioned to the sides of the retainer 120.

The retainer base is attached to the upper surface of the anchor pad110. The bottom surface preferably is secured to the upper surface by asolvent bond adhesive, such as cyanoacrylate or other bonding material.One such adhesive is available commercially from 3M.

A removable paper or plastic release liner desirably covers the adhesivelower surface before use. The release liner preferably resists tearingand desirably is divided into a plurality of pieces to ease attachmentof the anchor pad 110 to a patient's skin. In the illustratedembodiment, the release liner is split along a centerline of the anchorpad 110 in order to expose only half of the adhesive lower surface atone time.

As understood from the above description of the securement system 100shown in FIG. 1, the retainer 120 cooperates with a catheter hub 10 thatsecurely connect a connector fitting having a fluid tube (e.g., a fluidsupply line) to an indwelling catheter. The cooperation between abutmentsurfaces on the retainer 120 and the contact surfaces on the catheterhub maintains the catheter in the desired indwelling position. As isillustrated, for example in FIGS. 71 and 72, these abutment surfaces caninclude, for example, distal-most abutment surfaces 180 and intermediatesurfaces 160. The intermediate surfaces 160 lie between the proximal anddistal ends and are defined on the walls 170 and the base surface 140.The distal and intermediate abutment surfaces 180, 160 preferably areseparated by a distance that is generally equal to the longitudinallength L₁ of the first diameter 30(a) portion of the tubular body 30 ofthe catheter hub 10.

Additional Embodiments

Variations of the securement system 100 is described below in connectionwith FIGS. 31-45 and FIGS. 61-75 that have different incident angles andanchor pad outer profiles. In both of these embodiments, the channelaxis C is desirably skewed relative to the base surface 140 of theretainer 120. An incident angle θ defined between the base surface 140and the channel axis C preferably is less than 45°. More preferably, theincident angle θ ranges between 5° and 30°. The base surface 140 of theretainer 120 illustrated in FIGS. 31-45 has an incident angle ofapproximately 7°. The base surface 140 of the retainer 120 illustratedin FIGS. 61-75 has an incident angle of approximately 10°. Such incidentangles may be preferred when the retainer is used for intravenous use.In another exemplifying embodiment for arterial use, the incident angleθ may equal about 22°.

In the embodiments illustrated in FIGS. 31-45 and FIGS. 61-75, theanchor pad 110 further includes elongated extensions that project fromthe generally rectangular shape in a proximal direction. The elongatedsections form a concave section or notch that narrows the center of theanchor pad 110 proximate to the retainer 120 and on a proximal side ofthe pad 110. Only the shape of the anchor pad 110 and incident angle ofthe base surface 140 of these embodiments differ from theabove-described securement system 100. Accordingly, the abovedescription of the securement system 100 applies equally to theembodiments of FIGS. 31-45 and FIGS. 61-75, unless otherwise indicated.

Further variations of the retainer design are described below inconnection with FIGS. 16-30 and FIGS. 46-61 that have different incidentangles and include an adhesive covering at least a portion of thechannel 130. The incident angle of the base surface 140 for theembodiment illustrated in FIGS. 16-30 is approximately 7° while theincident angle of the base surface 140 for the embodiment illustrated inFIGS. 46-61 is approximately 10°.

As described above, inhibiting movement of the catheter hub 10 in thelongitudinal direction when the catheter is secured within the channel130 is desirably accomplished by the one or more abutment surfaces 160,180. In addition, the interaction between the contact area on the innersurface of the channel 130 and the tubular body 30 of the catheter hub10 creates friction to inhibit longitudinal movement through the channel130. Beyond just having contact between the catheter hub 10 and innersurface of the channel 130, the actual shape of the channel 130 itselfmay further inhibit movement. For example, the interaction between theshape of the channel 130 and a corresponding shape of the catheter hub10 inhibits longitudinal movement. Further, an adhesive cover placedover the top of the retainer and medical article can further inhibitrelative movement.

Another possible retention mechanism to inhibit axial movement of thecatheter hub 10 relative to the retainer 120 involves an adhesive spot240 as is most clearly illustrated in FIGS. 25 and 55. An adhesive spot240 may be advantageously disposed upon at least a portion of the insideof the channel 130. As is illustrated in FIG. 25, the adhesive spot 240may take a form which generally fills one or more recesses orreceptacles in the channel 130 while defining an outer surface that isdisposed with respect to the adjacent inner surface of the channel 130so as to contact the catheter hub 10 when the catheter hub 10 is placedwithin the channel 130. The adhesive spot 240 may extend into thechannel 130 so as to interfere and conform to the outer surface of thecatheter hub 10. The one or more recesses may be disposed in the walls170 and/or base surface 140. In the illustrated embodiment, recesses aredisposed in both walls 170 and the base surface 140. FIGS. 56 and 57illustrate the interfaces between the retainer 120 and the catheter hub10, including at the longitudinal location of the adhesive spot 240.

The adhesive spot may take the form of a glue dot. Such glue dots aredesirably formed of a material which exhibits high resistance to shearand which can be peeled off of the catheter without leaving a residue.Such an adhesive is sold by All-Pak Inc. of New Berlin, Wis. as partnumber GD-06 “Super High Tack Glue Dot.” Multiple glue dots may be used,or a single glue dot may be disposed on only one side of the channel ofthe retainer 120. It is not necessary for multiple glue dots to be used;a single glue dot disposed upon either the walls 170 or base surface 140may advantageously be used to provide greater frictional and/ortransverse forces between the retainer 120 and the catheter hub 10.

Furthermore, the adhesive spot 240 need not be a single point ofadhesive. In certain embodiments such as illustrated in FIG. 25, theadhesive spot 240 is a region composed of an elastic and compressivelydeformable material such Kraton polymer compounds. Such a compoundincludes Dynaflex G2706 available from GLS Corporation, as well as otherthermoplastic elastomers or silicone or urethane epoxies.

This region also need not be round. As is illustrated in FIG. 25, alarge region of the surface of the channel 130 is covered with asuitable material, such as Kraton. Alternatively, the entire surface ofthe base surface 140 might be covered with a thin layer of adhesive toadvantageously provide additional traction and transverse bias betweenthe catheter and retainer.

Other means of producing an appropriate adhesive spot 240 for use withvarious embodiments include without limitation: treating a portion ofthe surface of the channel 130 chemically or electrically to adjust itssurface friction or compressibility; spraying or spreading an adhesivecoating onto a portion of the grooves 210, 220 of the retainer;attaching peel-off adhesive members to portions of the channel;injection molding regions of adhesive or compressible material, such asKraton, to a portion of the surface of the channel; or such other meansas are known in the art.

Another retention mechanism to inhibit axial movement of the catheterhub 10 involves one or more friction ridges located on the contact areaof the channel 130. The ridges can be integrally formed with theretainer 120 and project into the channel 130. The ridges can liegenerally normal to the central axis C through the channel 130. When soarranged, the friction ridges gently, but securely bite or press into anouter surface of the catheter hub 10.

Another possible retention mechanism to inhibit axial movement of thecatheter hub 10 relative to the retainer 120 involves one or moresecurement barbs. The securement barbs can be used to retain thecatheter hub in the longitudinal direction. In certain embodiments, eachbarb has a generally conical shape with a blunt tip. The barb may extendinto the channel 130.

Of course, it is to be understood that not necessarily all such objectsor advantages may be achieved in accordance with any particularembodiment of the invention. Thus, for example, those skilled in the artwill recognize that the invention may be embodied or carried out in amanner that achieves or optimizes one advantage or group of advantagesas taught herein without necessarily achieving other objects oradvantages as may be taught or suggested herein. In addition to thevariations described herein, other known equivalents for each featurecan be incorporated by one of ordinary skill in this art to constructsecurement systems in accordance with principles of the presentinvention.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In particular, while the present retainer has been described inthe context of particularly preferred embodiments, the skilled artisanwill appreciate, in view of the present disclosure, that certainadvantages, features and aspects of the retainer may be realized in avariety of other applications, many of which have been noted above. Forexample, while particularly useful for small-scale applications, such asthe illustrated medical application, the skilled artisan can readilyadopt the principles and advantages described herein to a variety ofother applications, including larger scale devices. Additionally, it iscontemplated that various aspects and features of the inventiondescribed can be practiced separately, combined together, or substitutedfor one another, and that a variety of combination and subcombinationsof the features and aspects can be made and still fall within the scopeof the invention. Thus, it is intended that the scope of the presentinvention herein disclosed should not be limited by the particulardisclosed embodiments described above, but should be determined only bya fair reading of the claims that follow.

What is claimed is:
 1. A securement system for securing a medicalarticle to the skin of a patient, the system comprising: an anchor padhaving a lower surface at least partially covered by an adhesive forcontacting the patient's skin; a medical article having a generallyelongated tubular body, a ridge circumscribing at least a portion of thetubular body, and at least one spline extending generally perpendicularto the ridge and on either side of the ridge, the ridge defining acontact surface; and a retainer being supported by the anchor pad andhaving, a pair of upstanding walls separated by a base region to definea channel therebetween, a longitudinal access opening disposed on anupperside of the retainer, at least one groove disposed in the channeland generally parallel to the channel, the at least one groove beingsized and shaped so as to receive at least a portion of the spline whenthe medical article is secured within the retainer, and an abutmentsurface disposed in the channel and generally perpendicular to the atleast one groove, the abutment surface cooperating with the contactsurface on the medical article to inhibit longitudinal movement of themedical article relative to the retainer in at least one direction whenthe spline is disposed within the groove and the medical article issecured within the retainer.
 2. The system of claim 1, wherein theabutment surface is formed on one of the pair of walls and the baseregion.
 3. The system of claim 1, wherein the abutment surface is formedon the base region and each of the pair of wall.
 4. The system of claim1, wherein the abutment surface is discontinuous.
 5. The system of claim1, wherein the abutment surface circumscribes the channel forapproximately 180 degrees.
 6. The system of claim 1, wherein an incidentangle defined between the base region and a channel axis is between 0°and 45°.
 7. The system of claim 1, wherein the at least one groove isformed at an intersection of one of the pair of walls and the baseregion.
 8. The system of claim 1, wherein the medical article comprisesa second spline and the retainer comprises a second groove, the secondgroove being sized and shaped so as to receive at least a portion of thesecond spline.
 9. The system of claim 1 further comprising a distalabutment surface, the distal abutment surface being defined at least inpart by a distal edge of the pair of walls and disposed so as to contacta surface of the medical article at least when the medical article isdisposed within the retainer.
 10. The system of claim 1, wherein thechannel has a generally conical shape.
 11. The system of claim 1 furthercomprising an adhesive spot disposed so as to contact at least a portionof the medical article at least when the medical article is securedwithin the retainer.
 12. The system of claim 11, wherein the adhesivespot is disposed on the abutment surface.
 13. The system of claim 11,wherein the adhesive spot is disposed in the channel.
 14. A retainer forsecuring a medical article, the medical article having a generallyelongated tubular body, a ridge circumscribing at least a portion of thetubular body, and at least one spline extending generally perpendicularto the ridge and on either side of the ridge, the ridge defining acontact surface, the retainer comprising: a pair of upstanding wallsseparated by a base region to define a channel therebetween; at leastone groove disposed in the channel, the at least one groove being sizedand shaped so as to receive at least a portion of the at least onespline of the medical article; and an abutment surface disposed in thechannel and generally perpendicular to the at least one groove, the atleast one abutment surface cooperating with the contact surface toinhibit longitudinal movement of the medical article relative to theretainer in at least one direction at least when the spline is disposedwithin the groove and the medical article is secured within theretainer.
 15. The retainer of claim 14, wherein the abutment surface isformed on at least one of the pair of walls and the base region.
 16. Theretainer of claim 14, wherein the abutment surface is discontinuous. 17.The retainer of claim 14 further comprising a distal abutment surface,the distal abutment surface being defined at least in part by a distaledge of the pair of walls and disposed so as to contact a surface of themedical article at least when the medical article is disposed within theretainer.
 18. The retainer of claim 14 further comprising an adhesivespot disposed so as to contact at least a portion of the medical articleat least when the medical article is secured within the retainer.
 19. Amethod of securing a medical article to a patient, the medical articlehaving a generally elongated tubular body, a ridge circumscribing atleast a portion of the tubular body, and a pair of splines extendinggenerally perpendicular to the ridge and on either side of the ridge,the ridge defining a contact surface, the method comprising: providing aretainer having a channel, a pair of longitudinal grooves disposedwithin the channel and separated by a base surface, and at least oneabutment; locating the retainer with respect to the medical article soas to generally align the pair of splines with the pair of grooves; andpushing the medical article towards the channel so that at least aportion of the splines are received within the groves; and sliding thesplines of the medical article in the grooves until the contact surfaceof the medical article abuts the at least one abutment surface.
 20. Themethod of claim 19 further comprising adhering the retainer to thepatient's skin.